Biomet Begins IDE Trial for Stemless Shoulder Implant

Biomet Inc. reported on Oct. 21 the first U.S. implantation of the Comprehensive Nano Stemless Shoulder, which is part of a U.S. Food and Drug Administration investigational device exemption (IDE) multi-center prospective clinical study.

The first Comprehensive Nano IDE study patient was treated on Oct. 2 by Stephen Brockmeier, M.D., an orthopedic surgeon at University of Virginia Medical Center in Charlottesville, Va.

“We are excited to be a part of the clinical trial evaluating this potentially significant evolution in shoulder arthroplasty. I was impressed with the initial fixation of the stemless implant and was able to perform the shoulder replacement with minimal bone removal and components aligned with the patient’s natural anatomy,” Brockmeier said.

“I am excited to be a part of the team investigating the Comprehensive Nano,” said Jonathan Levy, M.D., of Holy Cross Hospital in Fort Lauderdale, Florida, a participant in the clinical study. “The procedure using the Comprehensive Nano allows me the potential to accurately restore shoulder anatomy without the limitations created by placing a stem within the humerus. The IDE study will allow us to objectively compare the efficacy of stemless and stemmed prostheses.”

Much of Warsaw, Ind.-based Biomet’s research and development effort has been into short-stem and stemless shoulder arthroplasty technology to address growing demand for less-invasive treatments. The Comprehensive Nano shoulder is part of the company’s Comprehensive line of products.

The Comprehensive Nano shoulder was developed based on the Biomet T.E.S.S. stemless shoulder, available in European and International markets since its launch in 2004.